MAUDE Adverse Event Report: CONMED UTICA CONMED; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Catalog Number	60-5163-001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 60-5163-001, laparoscopic electrode with a 3/32" pin connector, l-hook, was being used during an open procedure on 30apr25 when it was reported, ¿sing l-hook (settings at 30cut 30coag blend) staff noticed some of the black plastic part of the device had melted off in body.Melted piece and l-hook removed from body and taken out of circulation.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised to inspect the insulation on the instrument shaft.Do not use an instrument or electrode if the insulation is cracked, or damaged.This product is designed for non-continuous operation, with a duty cycle of 10 seconds on, and 30 seconds off.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 60-5163-001, laparoscopic electrode with a 3/32" pin connector, l-hook, was being used during an open procedure on (b)(6) 2025 when it was reported, ¿sing l-hook (settings at 30cut 30coag blend) staff noticed some of the black plastic part of the device had melted off in body.Melted piece and l-hook removed from body and taken out of circulation.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 60-5163-001, laparoscopic electrode with a 3/32" pin connector, l-hook, was being used during an open procedure on (b)(6) 2025 when it was reported, ¿sing l-hook (settings at 30cut 30coag blend) staff noticed some of the black plastic part of the device had melted off in body.Melted piece and l-hook removed from body and taken out of circulation.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Update: returned device evaluation has been added to manufacturer narrative.Manufacturer narrative: an examination of returned used 60-5163-001 device found that the molded plastic covering the rod was melted and deformed.Root cause cannot be determined, however, based upon the ifu; a possible cause of this event could be that the electrode insulation is cracked, or damaged.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 7 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised to inspect the insulation on the instrument shaft.Do not use an instrument or electrode if the insulation is cracked, or damaged.This product is designed for non-continuous operation, with a duty cycle of 10 seconds on, and 30 seconds off.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• Common Device Name: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 22094820
• Report Number: 1320894-2025-00142
• Device Sequence Number: 8060595
• Product Code: HFG
• UDI-Device Identifier: 30653405009768
• UDI-Public: (01)30653405009768(17)290414(10)202404151
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K904240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 60-5163-001
• Device Lot Number: 202404151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 09/09/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/10/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic